BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT

    MDR report key: 3706307 · Received March 27, 2014

    Report

    Report Number
    2953200-2014-00597
    Event Type
    Injury
    Date Received
    March 27, 2014
    Date of Event
    January 20, 2013
    Report Date
    March 4, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. TRAUMATIC INJURY OF THE THORACIC AORTA TREATED WITH STENT-GRAFT: IS LONG-TERM CT ANGIOGRAPHY FOLLOW-UP JUSTIFIED? U. RIMON, A. SHINFELD, G. GAYER. ELSEVIER LTD; (2014) E1-E4. THE FOLLOWING ADVERSE EVENTS WAS OBSERVED: OCCLUSION. NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT. AIM: TO REPORT THE RESULTS OF LONG-TERM (>5 YEARS) COMPUTED TOMOGRAPHY (CT) ANGIOGRAPHY FOLLOW-UP AFTER THORACIC ENDOVASCULAR AORTIC REPAIR IN PATIENTS WITH TRAUMATIC THORACIC AORTIC INJURY. MATERIALS AND METHODS: ALL FOLLOW-UP CT ANGIOGRAPHIES PERFORMED IN PATIENTS WITH TRAUMATIC THORACIC AORTA INJURY TREATED BY ENDOVASCULAR STENT-GRAFT BETWEEN 2002 AND 2008 WERE REVIEWED. OF THE 14 PATIENTS TREATED, SEVEN PATIENTS HAD CT ANGIOGRAPHY FOLLOW-UP EXAMINATIONS FOR MORE THAN 5 YEARS. ALL PATIENTS WERE MEN WITH A MEAN AGE OF 26 YEARS. THE TALENT DEVICE WAS USED IN FOUR PATIENTS AND GORE TAG DEVICE IN THREE PATIENTS. THE MEAN DEVICE DIAMETER AND LENGTH WERE 24.6 MM AND 103 MM, RESPECTIVELY. FOLLOW-UP INCLUDED ANNUAL OUTPATIENT CLINIC SURVEILLANCE AND CT ANGIOGRAPHY EXAMINATIONS, WHICH WERE REVIEWED FOR ANY DEVICE-RELATED COMPLICATIONS. THE RADIATION EFFECTIVE DOSE WAS CALCULATED FROM THE CT DOSE REPORT. RESULTS: THIRTY-THREE CT EXAMINATIONS PERFORMED 64E110 MONTHS (MEAN 76) AFTER STENTGRAFT IMPLEMENTATION WERE REVIEWED. THE MEAN FOLLOW-UP NUMBER OF EXAMINATIONS PER PATIENT WAS 4.7 (RANGE 2E8). INTRA-GRAFT CIRCULAR MURAL TISSUE AT THE DISTAL PART OF THE STENT-GRAFT WAS SEEN IN ONE PATIENT. STABLE LACK OF PROXIMAL DEVICE APPOSITION WAS SEEN IN ALL PATIENTS. NO OTHER RADIOLOGICAL COMPLICATIONS (E.G., AORTIC INFECTION, DILATATION, ANEURYSM OR PSEUDOANEURYSM, DEVICE STRUTS BREAKAGE, MIGRATION, COLLAPSE, ENDOLEAK) WERE DETECTED. NONE OF THE PATIENTS DEVELOPED HYPERTENSION. THE AVERAGE EFFECTIVE DOSE WAS 77.01 MSV (RANGE 34.11E128.84 MSV). CONCLUSION: CT ANGIOGRAPHY DID NOT REVEAL ANY COMPLICATIONS DEVELOPING THROUGHOUT THE LONG-TERM FOLLOW-UP. THESE RESULTS SUGGEST THAT LONG-TERM CT ANGIOGRAPHY FOLLOW-UP MAY NOT BE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179952 TALENT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00026 YR